ACETAMINOPHEN-SL ASSAY— 510(k) K042330

Clearance details

Applicant

Diagnostic Chemicals , Ltd.

Product code

Code LDP

Device class

Class 2

Regulation

21 CFR 862.3030

Advisory panel

Clinical Toxicology

Date received

2004-08-27

Decision date

2005-01-07

Decision

Substantially Equivalent

Clearance type

Traditional

Location

Charlottetown, Prince Edward, CA

• K261364 — Atellica CH Acetaminophen 2 (ACTM)2026-07-24
• K202644 — Acetaminophen2022-02-18
• K180835 — SEKURE Acetaminophen L3K Assay2019-02-08
• K110726 — ROCHE ACETAMINOPHEN ASSAY2011-12-23
• K100200 — ADVIA CHEMISTRY ACETAMINOPHEN REAGENT, MODEL REF 079891382010-08-02

• K070383 — ENZYMATIC CREATININE ASSAY (265 SERIES)2007-06-22
• K063208 — MAGNESIUM ASSAY (XB), MODELS 125-12, 125-50 AND 125-S72007-01-19
• K060139 — CRP-ADVANCE ASSAY, MODELS 250-20, 250-252006-04-28
• K060140 — CRP-ADVANCE MULTI CALIBRATOR SET, MODEL SE-2502006-04-24
• K051757 — CALCIUM ADVANCE ASSAY, MODEL 145-20, 145-25, 145-20-912005-11-10

Other

1

Total

1

Source: openFDA MAUDE database, 2020-01-01 through 2026-04-23. Counts aggregate all devices under this product code, not just this specific clearance. Reports are submissions to FDA, not validated events. Search MAUDE directly →

• Z-1902-2012 — MULTIGENT Acetaminophen for use with Architect/Aeroset Cat. No. 2K99-20. Assay is intended for the quantitative determination of acetaminophen in human serum or plasma.Class II·Terminated·Sekisui Diagnostics Llc·20120529

Matched by K-number from FDA's Recall Enterprise System record (openFDA device/recallk_numbers) — these recalls explicitly list K042330.